📃 Hyaluronic acid has established itself as a key segment of the injectable medical device market, in both aesthetic medicine and orthopaedics. Driven by Regulation (EU) 2017/745 (MDR), the ISO 10993-18 standard and increasingly complex formulations, requirements now extend well beyond the purely analytical scope.
Analytical challenges to anticipate for hyaluronic acid
🎯 Several aspects are now decisive for manufacturers in the sector :
- Characterising increasingly complex gels
- Controlling critical impurities (BDDE, solvents, elemental impurities)
- Interactions between components and with the packaging
- Generating data compliant with MDR, ISO, ICH and Pharmacopoeia standards
In this context, generating analytical results is no longer sufficient. The ability to interpret data in light of the product’s characteristics and regulatory expectations is essential to support compliance and secure market access.
CEBIPHAR, your analytical partner for hyaluronic acid
For over 15 years, CEBIPHAR has supported industry players across the entire life cycle of hyaluronic acid-based products, from raw materials to finished products :
- Quality control of raw materials
- Control of sodium hyaluronate (EP1472)
- Molecular weight: Mn, Mw, and polydispersity (HPLC – RI or UV)
- Development of a BDDE control monograph
- BDDE assay according to ICH M7
- Control of excipients according to the Chinese Pharmacopoeia
- Characterisation of injectable gels
- HA assay (carbazole and HPLC)
- Lidocaine assay and its impurities (2,6-DMA – spec level 1 ppm)
- Assay of other anesthetic APIs and their impurities
- BDDE assay and its impurities (spec level 2 ppm) by GC and HPLC
- Analysis of residual proteins
- Rheological characterization and viscosity (Standard viscosity, Zero shear viscosity, Cross over frequency)
- Stability and product behaviour studies
- Stability studies according to ICH (storage and analysis)
- Transport studies and temperature excursions
- Stability assessment at 2°C
- Enzymatic and radical kinetic degradation studies (in-vitro simulation)
- Integrity and compliance testing
- Container integrity: CCIT test validation
- Structural identification of impurities
- Chemical characterization (extractables and leachables) according to ISO 10993-18
- Identification of elemental impurities and residual solvents (ICH Q3C & ICH Q3D)
- Particulate contamination (USP 788)
🤝 What sets CEBIPHAR apart
- Compliance : mastery of regulatory requirements (MDR, ICH, European Pharmacopoeia)
- Agility : adaptation to each product and each client context
- Science : in-depth understanding of injectable hyaluronic acid-based products
- Trust : reliability of results and a lasting relationship of confidence
📩 Developing a hyaluronic acid-based product ? Let’s talk !
